Pralsetinib (Gavreto®) – Non-small cell lung cancer (NSCLC), RET fusion+

Characteristics

Start date 15.12.2021
Resolution 16.06.2022
Limitation date 31.12.2027
INN Pralsetinib
Brand name Gavreto®
Pharm. company Roche Registration GmbH
G-BA procedure ID 2021-12-15-D-757
ATC code L01EX23
Therapeutic area Oncological diseases
Reason for procedure Initial assessment

Indication (German)

Gavreto is used as monotherapy for the treatment of adult patients with

rearranged-through-transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) who have not been previously treated with a RET inhibitor.

Subpopulation Indication Comparator
a) Adults with RET fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50 % of tumour cells; first-line therapy Pembrolizumab as monotherapy
b) Adults with RET fusion-positive, advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% of tumour cells; first-line therapy. Cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with nab-paclitaxel or - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients without EGFR- or ALK-positive tumour mutations and with non-squamous histology) or pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only with squamous histology) or - monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment)
c) Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. Cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) or - carboplatin in combination with nab-paclitaxel or Monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment)
d) Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC) after first-line therapy with cytotoxic chemotherapy. Docetaxel (only for patients with PD-L1 negative tumours) or - Pemetrexed (only for patients with PD-L1 negative tumours and except in the case of predominantly squamous histology) or - Nivolumab or - pembrolizumab (only for patients with PD-L1 expressing tumours, PD-L1 tumours, PD-L1 expression ≥ 1 % of tumour cells) or - atezolizumab or - Docetaxel in combination with nintedanib (only for patients with PDL1 negative tumours and adenocarcinoma histology).
e) Adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC); after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and platinum-containing chemotherapy. Patient-specific therapy with selection of - afatinib - pemetrexed - erlotinib - docetaxel - Docetaxel in combination with ramucirumab - Docetaxel in combination with nintedanib - vinorelbine taking into account previous therapy and histology

9. Associated procedures



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